Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
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DOI：
10.1056/nejmoa1915745
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发表时间：
2020-05-14
影响因子：
158.5
通讯作者：
Cheng, Ann-Lii
中科院分区：
文献类型：
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作者：
Finn, Richard S.;Qin, Shukui;Cheng, Ann-Lii
BackgroundThe组合atezolizumab和贝伐单抗显示出令人鼓舞的抗肿瘤活性和安全性，在1b期试验涉及患者不可切除的hepatocellular carcinoma.MethodsIn一个全球性的，开放标签，3期试验，患者不可切除的肝细胞癌谁以前没有接受系统性治疗被随机分配在2：1的比例接受atezolizumab加贝伐单抗或索拉非尼，直到不可接受的毒性作用发生或有临床获益的损失。共同主要终点是意向治疗人群的总生存期和无进展生存期，根据实体瘤反应评价标准1.1版（RECIST 1.1）在独立审查机构进行评估。结果意向治疗人群包括atezolizumab-贝伐单抗组336例患者和索拉非尼组165例患者。在主要分析时（2019年8月29日），atezolizumab-贝伐珠单抗与索拉非尼相比的死亡风险比为0.58（95%置信区间[CI]，0.42至0.79; P
BackgroundThe combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.MethodsIn a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).ResultsThe intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (August 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42 to 0.79; P